35+ Years — Biomedical engineering & FDA regulatory experience
14 Expert Reports
8 Depositions
2 Trial Testimonies
Plaintiff & Defense - Retained by both sides of the aisle
My Services
Expert Witness Services
I provide testimony, deposition, and trial support, offering invaluable insights that strengthen legal arguments and bolster case strategies.
Technical Analysis
I conduct thorough technical analyses of medical devices, identifying potential defects, failures, or regulatory non-compliance to support liability claims and inform litigation strategies.
Regulatory Compliance Review
Leveraging my deep understanding of medical device regulations, I assist legal teams in assessing compliance issues, evaluating standards of care, and interpreting complex regulatory frameworks.
Areas
of
Expertise
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Pelvic mesh & hernia mesh
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Orthopedic implants (hip, spine, total joint)
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Cardiac valves
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Class II & Class III device design controls
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FDA Quality System Regulation (21 CFR Part 820)
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ISO 13485, MDSAP, EU MDR, IVDR
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Complaints, adverse events & post- market compliance
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Risk management, CAPA & root cause analysis
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Supply chain & manufacturing quality audits